Table of drug clinical trials

Clinical
trials began in December 2014. Preliminary data presented in February 2015
does not permit a firm conclusion regarding efficacy and more data is
required; trial continues.

The
drug has been administered to around 200 patients who received 9 days of oral
treatment. There is no control group.

The
trial is at ETUs in Gueckedou, Nzerekore, Donka, and Conakry and is led by
INSERM with funding from the European Commission.

The
EU has announced preliminary findings from these trials which show the
antiviral may be effective in treating patients with early stage EVD. In
adults and adolescents with a low to moderate viral load, the case fatality
rate was 15% (vs 30%, historically). WHO is taking a cautious interpretation
given the lack of concurrent controls in the study.

A
clinical trial started in early March 2015 in Port Loko, Sierra Leone, led by
Oxford University with funding from the Wellcome Trust.

The
trial was halted on 19 June on the grounds of having met one of the clinical
endpoints. Continuing enrolment was not likely to demonstrate an overall
therapeutic benefit.

ZMapp

MappBio
USA

Phase
II

By
NIAID in

Liberia,
Sierra Leone and the United States of America

Cocktail
of three monoclonal antibodies with neutralizing activity against Ebola virus
in animal models. Treats 100% of infected non-human primates (NHP). The
product has been used on several patients under compassionate use.

A
multi-country, multisite randomized controlled trial opened to enrollment in
Liberia and the United States in February 2015 and in Sierra Leone in March
2015. Enrollment is ongoing – currently, more than 35 patients have been
enrolled.

No
data on efficacy is available yet.

Preparations
to extend this trial to Guinea (in collaboration with INSERM) are in
progress.

MIL-77

MabWorks,
China

Phase
I

Cocktail
of three monoclonal antibodies with the same sequence as the monoclonals in
Zmapp, yet made in CHO cells.

Efficacy
in monkeys comparable to Zmapp.

To
date, used in two expatriated patients under compassionate use.

IND
for Phase I filed in China.

Prioritized
for use on Ebola patients in condition of not interfering with the clinical
assessment of efficacy of Zmapp.

BCX-4430

Biocryst,
USA

Phase
I

By
Quotient Clinic in the UK

Broad-spectrum
direct-acting nucleoside analogue.

Phase
I safety trial is underway. No efficacy trial is planned until safety data
have been analysed.

Interferons

Phase II

By
Guinea MOH in

Coyah,
Guinea

Approved
for treatment of HepB and C and multiple sclerosis.

Guinean
authorities, in collaboration with Canadian scientists, launched a clinical
study of an interferon in Ebola-infected patients. Due to risks of symptom
exacerbation, enrollment limited to patients with recent symptom onset. To
date, 9 patients have been enrolled in the trial.

Amiodarone

Observational

At
the Lakka & Goderich ETU in

Sierra
Leone

Used
to treat cardiac dysrhythmia.

Was
used compassionately in approximately 80 patients in Sierra Leone and
reportedly reduced case fatality ratio when compared with local historical
norms. The statistical significance of this result is not known due to
variations in case fatality rates across sites and over time.

Apparently
used to treat some patients in Sierra Leone, however, there has been no
confirmation from the treatment centres that such studies took place, and no
clinical data on the patients are available. Therefore, no conclusion on
utility, safety or efficacy is possible.

FX06

Peptide
for use in treating vascular leakage.

Administered
compassionately to two patients. No conclusions can be drawn yet.

Administered
on a compassionate basis to a few patients when other products are not available.

Amodiaquine

Médecins
Sans Frontiéres (MSF)

Antimalarial
products were provided to all patients entering Ebola treatment centres. When
MSF switched from an antimalarial containing lemefantrine to one containing
amodiaquine, the case fatality rates dropped.

It
is not known if this is due to efficacy of amodiaquine against Ebola or to
toxicity of lemefantrine in patients with EVD.

Brincidofovir

Chimerix,
USA

Phase
II

By
Oxford University at the

ELWA
3 Clinic, Monrovia, Liberia

An
antiviral used to treat CMV.

Clinical
trial halted and abandoned; the drug has been deprioritized for use in Ebola
treatment.